The Medical Device Business Journal — Medical Device News & Articles | MassDevice
North Andover, Mass.-based startup MindChild Medical landed a research partnership with Oxford University dedicated to developing signal processing software with MindChild’s Meridian, a non-invasive fetal heart rate data monitor.
MindChild Medical received 510(k) clearance from the U.S. FDA for a new fetal heart monitor the company says can detect tiny fluctuations in fetal heartbeats and potentially reduce the number of Caesarean sections pregnant women undergo.
Company officials said the regulatory win clears the way for the company to commercialize its Meridian non-invasive fetal heart monitor.
St. Jude Medical Inc. (NYSE:STJ) won pre-market approval for 2 next-generation cardiac ablation systems this month, the Therapy Cool Path Duo and Safire Blu Duo catheters.
Both ablation systems use radiofrequency energy to freeze small areas of faulty cardiac tissue in patients with typical trial flutter, a type of arrhythmia in which patients experience abnormal heart rhythms or an abnormally fast heartbeat in the upper chambers of the heart.
Quintiles is resuming its plans to raise more than $2 billion in bank financing.
The Durham, N.C.-based, contract research organization is planning to enter into a new $2.2 billion credit facility, with proceeds from the borrowed funding being used to refinance $1.7 billion in existing debt, including an offer to buy $525 million of 9.5 percent outstanding senior notes that are due in 2014.
Six medical device makers in Massachusetts and Connecticut raised more than $2.6 million in various fundraising offerings during May and June, according to regulatory filings.
Audax Medical of Littleton, Mass., pulled in just more than $686,000 in a pair of equity offerings, according to filings filings with the Securities & Exchange Commission.
